VII. Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). (closed to patient accrual 3/9/15)

VIII. Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points.

ARM I: Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using IMRT* or 3D-conformal radiation therapy (3D-CRT)* QD, 5 days a week, for approximately 9 weeks. Patients may also undergo PPI brachytherapy or high-dose rate brachytherapy (iodine I 125 or palladium Pd 103 may be used as the radioisotope).

ARM II: Patients undergo WPRT* (3D-CRT or IMRT) QD, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in Arm I.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

Eligibility Criteria

Inclusion Criteria:

Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:

Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure

History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration

Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or dissection) within 90 days prior to registration

Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.5 cm

No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute)

Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration

Study entry PSA should not be obtained during the following time frames:

10-day period following prostate biopsy

Following initiation of hormonal therapy

Within 30 days after discontinuation of finasteride

Within 90 days after discontinuation of dutasteride

Zubrod performance status 0-1 (unless otherwise specified)

Absolute neutrophil count (ANC) >= 1,500/mm³

Platelets >= 100,000/mm³

Hemoglobin (Hgb) >= 8.0 g/dL (Note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable)

Patient must be able to provide study specific informed consent prior to study entry

Exclusion Criteria:

Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy not allowed

Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients

Patients who are sexually active and not willing/able to use medically acceptable forms of contraception

Note: Information about participating sites on pharmaceutical industry trials may be incomplete.
Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.